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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05257408




Registration number
NCT05257408
Ethics application status
Date submitted
4/02/2022
Date registered
25/02/2022
Date last updated
5/08/2024

Titles & IDs
Public title
Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
Scientific title
A Phase 3 Study of Relacorilant in Combination With Nab-Paclitaxel Versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA)
Secondary ID [1] 0 0
ROSELLA Study 556
Secondary ID [2] 0 0
CORT125134-556
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasm 0 0
Fallopian Tube Neoplasms 0 0
Peritoneal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nab-paclitaxel 80 mg/m^2
Treatment: Drugs - Relacorilant 150 mg once daily (QD)
Treatment: Drugs - Nab-paclitaxel 100 mg/m^2

Experimental: Nab-paclitaxel 80 mg/m^2 with Relacorilant 150 mg - Patients receive nab-paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle in combination with intermittent relacorilant (150 mg relacorilant once daily on the day before, the day of, and the day after nab-paclitaxel), administered orally under fed conditions. Relacorilant will not be administered on Cycle 1 Day -1.

Active comparator: Nab-paclitaxel 100 mg/m^2 - Patients receive nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle.


Treatment: Drugs: Nab-paclitaxel 80 mg/m^2
Nab-paclitaxel is administered as intravenous (IV) infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle.

Treatment: Drugs: Relacorilant 150 mg once daily (QD)
Relacorilant is administered as capsules for oral dosing.

Treatment: Drugs: Nab-paclitaxel 100 mg/m^2
Nab-paclitaxel is administered as IV infusion on Day 1, 8, and 15 of each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival as Assessed by BICR
Timepoint [1] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [2] 0 0
PFS as Assessed by the Investigator
Timepoint [2] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [3] 0 0
Objective Response as Assessed by BICR
Timepoint [3] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [4] 0 0
Best Overall Response as Assessed by BICR
Timepoint [4] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [5] 0 0
Duration of Response as Assessed by BICR
Timepoint [5] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [6] 0 0
Clinical benefit rate as assessed by BICR
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
Cancer Antigen (CA)-125 Response
Timepoint [7] 0 0
Up to 24 months from enrollment of the last patient
Secondary outcome [8] 0 0
Combined Response According to RECIST v1.1 and GCIG Criteria
Timepoint [8] 0 0
Up to 24 months from enrollment of the last patient

Eligibility
Key inclusion criteria
* Signed and dated Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to study-specific screening procedures.
* Confirmed histologic diagnosis of high-grade (Grade 3) serous, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
* Patients must have platinum-resistant disease (defined as RECIST v1.1 defined progression <6 months from completion of a platinum-containing therapy).
* Must consent to provide archival tumor-tissue block or slides. Patients may consent to an optional tumor biopsy if archival tumor is unavailable.
* Has a life expectancy of =3 months.
* At least one lesion that meets the definition of measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Able to comply with protocol requirements.
* Able to swallow and retain oral medication and does not have uncontrolled emesis.
* Received at least 1 but =3 lines of prior systemic anticancer therapy and at least 1 prior line of platinum therapy and prior treatment with bevacizumab is required.
* Has adequate organ function meeting the following laboratory-test criteria: Absolute neutrophil count (ANC) =1500 cells/mm^3, Platelet count =100,000/mm^3, Hemoglobin =9 g/dL, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 × upper limit of normal (ULN), or =5 × ULN in context of liver metastases, Total bilirubin =1.5 × ULN, and Albumin =3 g/dL, and creatinine clearance >40 mL/min/1.73 m^2 (measured or estimated).
* Negative pregnancy test for patients of childbearing potential; patients of childbearing potential must agree to use highly effective contraceptive method(s); hormonal contraceptives are not allowed.
* Coronavirus disease (COVID-19) approved vaccines are accepted concomitant medications when recommended by the Investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has clinically relevant toxicity from prior systemic anticancer therapies or radiotherapy that has not resolved to =Grade 1 prior to randomization.
* Has had any major surgery within 4 weeks prior to randomization.
* Has low-grade endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of these histologies, or low-grade or borderline ovarian tumor.
* Has primary platinum-refractory disease, defined as disease that did not respond to or has progressed =1 month of the last dose of first-line platinum-containing chemotherapy.
* Has not received prior bevacizumab treatment.
* Has been treated with the following prior to randomization: chemotherapy, immunotherapy, investigational agent treatments for disease under study within 28 days before first dose of study drug, radiotherapy not completed at least 2 weeks prior to first dose of study drug, hormonal anticancer therapies within 7 days of first dose of study drug, and systemic, inhaled, or prescription strength topical corticosteroids within 21 days of first dose of study drug.
* Has received wide-field radiation to more than 25% of marrow-bearing areas.
* Has toxicities of prior therapies that have not resolved the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, =Grade 1.
* Requires treatment with chronic or frequently used oral corticosteroids for medical conditions or illnesses.
* Has a history of severe hypersensitivity or severe reaction to any of the study drugs.
* Is receiving concurrent treatment with mifepristone or other glucocorticoid receptor (GR) modulators.
* Has peripheral neuropathy from any cause >Grade 1.
* Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial, starting with the screening visit through at least 1 month after the last dose of relacorilant, or 6 months after the last dose of nab-paclitaxel whichever is the longest.
* Has clinically significant uncontrolled condition(s) or condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation.
* Has current chronic/active infection with human immunodeficiency virus or current chronic/active infection with hepatitis C virus or hepatitis B virus.
* Has any untreated or symptomatic central nervous system (CNS) metastases.
* Patients with a history of other malignancy within 3 years prior to randomization
* Is taking a concomitant medication that is a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer, or that is a substrate of CYP3A with a narrow therapeutic window.
* Concurrent treatment on other investigational treatment studies for the treatment of ovarian, fallopian tube, or primary peritoneal cancer.
* Has received a live vaccine within 30 days of prior to the study start date.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site 426 - St. Leonards
Recruitment hospital [2] 0 0
Site 417 - Benowa
Recruitment hospital [3] 0 0
Site 414 - Melbourne
Recruitment hospital [4] 0 0
Site 419 - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
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Massachusetts
Country [11] 0 0
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State/province [11] 0 0
New Jersey
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New Mexico
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New York
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Ohio
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Oregon
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Pennsylvania
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South Dakota
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Tennessee
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Texas
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Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
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Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Cordoba
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Belgium
State/province [26] 0 0
Aalst
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Charleroi
Country [29] 0 0
Belgium
State/province [29] 0 0
Hasselt
Country [30] 0 0
Belgium
State/province [30] 0 0
Leuven
Country [31] 0 0
Belgium
State/province [31] 0 0
Liège
Country [32] 0 0
Brazil
State/province [32] 0 0
Bahia
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Brazil
State/province [33] 0 0
Brasília - DF
Country [34] 0 0
Brazil
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Ceara
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Norte
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Brazil
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SP
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Brazil
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Porto Alegre
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Brazil
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Rio De Janeiro
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Brazil
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São Paulo
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Canada
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Ontario
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Canada
State/province [42] 0 0
Quebec
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France
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Lille
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France
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Montpellier
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France
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Nancy
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France
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Nice
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France
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Paris
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France
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Plérin
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Hungary
State/province [49] 0 0
Budapest
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Hungary
State/province [50] 0 0
Debrecen
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Hungary
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Gyor
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Tel Aviv
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Italy
State/province [55] 0 0
Catania
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Italy
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Legnago
Country [57] 0 0
Italy
State/province [57] 0 0
Milano
Country [58] 0 0
Italy
State/province [58] 0 0
Pavia
Country [59] 0 0
Italy
State/province [59] 0 0
Roma
Country [60] 0 0
Italy
State/province [60] 0 0
Rome
Country [61] 0 0
Italy
State/province [61] 0 0
Torino
Country [62] 0 0
Italy
State/province [62] 0 0
Treviso
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gyeonggi-do
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Seoul
Country [65] 0 0
Poland
State/province [65] 0 0
Gdynia
Country [66] 0 0
Poland
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Poznan
Country [67] 0 0
Poland
State/province [67] 0 0
Siedlce
Country [68] 0 0
Spain
State/province [68] 0 0
Badalona
Country [69] 0 0
Spain
State/province [69] 0 0
San Sebastián
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
United Kingdom
State/province [71] 0 0
East Sussex
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Somerset
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Cheltenham
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Manchester
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corcept Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gynecologic Oncology Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.
Trial website
https://clinicaltrials.gov/study/NCT05257408
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sachin Pai, MD
Address 0 0
Corcept Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05257408